Efficacy and Safety of FMT for the Decolonization of MDROs in the Intestinal Tract

NCT06001333 | Recruiting

• 1 other identifier: 2023-06-007
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this unblinded randomized controlled trial is to evaluate the efficacy and safety of fecal microbiota transplantation for the decolonization of carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE) or vancomycin-resistant Enterococci (VRE) in the intestinal tract. The study is planned to be conducted to test the superiority hypothesis that the decolonization success rate in the FMT group is higher compared to the non-FMT group. Outcome analysis will be conducted through intention-to-treat analysis, modified intention-to-treat analysis, and per-protocol analysis. The main questions it aims to answer are:

• primary endpoint: Rate of Decolonization of Multidrug-Resistant Organisms (CP-CRE or VRE) at 1 Month After Fecal Microbiota Transplantation (FMT).
• secondary endpoint: Rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 year after FMT / Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate. Patients colonized with multidrug-resistant organisms in the gastrointestinal tract are divided into two groups through obtaining written consent from the patients and random allocation: the Fecal Microbiota Transplantation group (FMT group), which receives FMT, and the control group (non-FMT group), which is observed without FMT. The decolonization status of multidrug-resistant organisms will be monitored every 3-7 days after FMT until three consecutive negative results.

Conditions

Carbapenem-Resistant Enterobacteriaceae; Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)

Keywords

Carbapenem-Resistant Enterobacteriaceae; Vancomycin-Resistant Enterococci; Fecal Microbiota Transplantation; Gastrointestinal Microbiome

Outcome Measures

Primary Outcomes (1)

• Rate of Decolonization of Multidrug-Resistant Organisms at 1 Month After Fecal Microbiota Transplantation (FMT)

  The decolonization rate at 1 month after FMT refers to the proportion of achieving three consecutive negative results within 1 month after the FMT procedure.

  at 1 Month After Fecal Microbiota Transplantation (FMT)

Secondary Outcomes (2)

• rates of Multidrug-Resistant Organism decolonization at 3 months, 6 months, and 1 year after Fecal Microbiota Transplantation (FMT)

  at 3 months, 6 months, and 1 year after Fecal Microbiota Transplantation (FMT)

• Post-FMT Multidrug-Resistant Organism Recolonization Rate and Infection Rate within 1 year after FMT

  within 12 months after FMT

Study Arms (2)

FMT group

EXPERIMENTAL

fecal microbiota transplantation using frozen or capsulized stool

Procedure: fecal microbiota transplantation

non-FMT group

NO INTERVENTION

Simple observation without intervention

Interventions

fecal microbiota transplantation PROCEDURE

Fecal microbiota transplantation will be conducted on patients using donor stool (frozen or capsulized stool) from a stool bank.

FMT group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 20 and older.
• Those with confirmed carbapenemase-producing Enterobacteriaceae (CPE) from a rectal swab culture within the past week (class A, B, or D CPE).
• Those with confirmed vancomycin-resistant Enterococci (E. fecalis or E. faecium) from a rectal swab culture within the past week.
• Individuals who have agreed to undergo Fecal Microbiota Transplantation (FMT) procedures and to provide pre- and post-procedure stool samples.
• Individuals who have discontinued antibiotics for a period of 3 to 7 days prior to FMT procedure.

You may not qualify if:

• Patients with ongoing or anticipated acute treatment, including antibiotic therapy.
• Individuals with severe immunodeficiency.
• Cases where there is a risk due to upper gastrointestinal endoscopy or colonoscopy.
• Pregnant individuals, those who could become pregnant, and breastfeeding women.
• Cases where participation in the study is determined by the researcher not to be beneficial.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead
• Severance Hospital: collaborator
• National Institute of Health, Korea: collaborator

Study Sites (2)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Seung Soon Lee, MD, PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Soon Lee, MD, PhD

CONTACT

+82-10-3379-9347; hushh93@gmail.com

Jun Yong Choi, MD, PhD

CONTACT

+82-10-4073-9253; seran@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: September 18, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)